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A preprint, an unpublished non-peer reviewed study, from the RECOVERY trial, reports no benefit from azithromycin, a widely used antibiotic, in patients hospitalised with COVID-19.
Caroline Cake, CEO of Health Data Research UK, said:
“Findings such as today’s news that azithromycin is not an effective treatment for patients hospitalised with COVID-19 may seem disappointing in the first instance. But as we know, ruling out treatments in this way is an equally important outcome of clinical trials.
“The RECOVERY trial is rightly held up as an exemplar for clinical trials and has already given us a substantial break through treatment for Covid-19. At the heart of the trial’s success has been the ability to securely and very quickly pull together a number of large scale datasets from a variety of locations in the NHS, including demographic information, GP records, treatments and deaths from hospital records, as well as Covid-19 test results from government and NHS services.
“At the heart of this work is NHS DigiTrials – one of eight specialist Health Data Research UK (HDR UK) hubs – set up precisely for this purpose; to enable the connections between clinical trials data, NHS data and other datasets to produce the type of important discovery we have seen today.”
Dr Nick Cammack, Covid-19 Therapeutics Accelerator Lead at Wellcome, said:
“It is disappointing that azithromycin shows no clinical benefit against Covid-19 in hospitalised patients, but large-scale randomised clinical studies like RECOVERY are essential for providing the world with definitive answers.
“Progress has been made in the search for effective Covid-19 treatments, with dexamethasone benefitting moderate to seriously ill patients, but the deficit of effective treatments remains deeply concerning. Even as vaccines become available, treatments are urgently needed to reduce further deaths and suffering, and keep pressure off health systems around the world.
“The Covid-19 monoclonal antibodies are among the most exciting treatments on the horizon because they are specific to the disease. To ensure promising treatments like these can be rapidly rolled out in low-resource settings in 2021, the ACT-Accelerator needs $750 million immediately.
“Covid-19 can be a preventable and treatable disease, but only if we invest in research now and make these tools available to everyone who needs them.”
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
“The RECOVERY trial is now well known as a platform for testing a variety of treatments and has been able to recruit large numbers of patients with Covid-19 who are in hospital. It has shown that the trial design is capable of detecting benefits for dexamethasone, and shown convincingly that the other treatments it has tested in hospitalised patients show no or the possibility of only small, benefit in terms of mortality or length of hospital stay. It is a well-designed and conducted trial answering relatively simple questions with recruitment of large numbers of patients. It can give reliable and precise answers.
“The antibiotic azithromycin has been suggested as having benefits, particularly when used in combination with hydroxychloroquine, but RECOVERY has only studied them separately. Neither have been shown to have benefit in terms of mortality, and in the randomised trials conducted by others on the combination of the two drugs no notable benefits have been seen.
“This trial report, while preliminary, makes it clear that as the authors say “The results of this large randomised trial show that azithromycin is not an effective treatment for patients hospitalised with COVID-19. Allocation to azithromycin was not associated with reductions in mortality, duration of hospitalisation or the risk of being ventilated or dying for those not on ventilation at baseline.”
“Those who should definitely receive the antibiotic for a bacterial infection or who should definitely not receive it (because of underlying health conditions) were excluded. It shows that patients who could receive it as an option showed neither benefit nor harm.”
Dr Sheuli Porkess, Chair of the Policy and Communications Group, Faculty of Pharmaceutical Medicine:
“This news shows the ongoing benefit of having clinical trial platforms which are able to provide robust answers to questions about medicines for COVID-19.
“Whilst it is disappointing that azithromycin did not show any meaningful benefit in terms of mortality for patients who had been hospitalised with COVID-19, this information is still very important to guide clinicians as they make decisions about how to treat patients.
“Having this information is particularly important in the case of azithromycin because azithromycin is an antibiotic and antibiotics should only be used where there is a clear need, in order to minimise antimicrobial resistance.”
Dr Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said:
“Once again, this preliminary analysis of an arm of the RECOVERY trial demonstrates the value of robust RCTs in the assessment of repurposed therapies for COVID. Whilst Azithromycin, sometimes combined with hydroxychloroquine, has been proposed as a therapy in smaller studies and anecdotal accounts, it has never been clear exactly what its mode of action might be versus SARS-CoV2, or whether its anti-inflammatory properties are effective in combatting the immune pathology associated with severe disease. Like hydroxychloroquine, it is now clear that healthcare professionals can, with some confidence, stop prescribing this drug to hospitalised patients and instead focus upon medicines with proven benefit.”
Preprint (not a paper): ‘Azithromycin in Hospitalised Patients with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial’ by the RECOVERY Collaborative Group was posted on medRxiv at 13:00 UK time on Monday 14 December 2020. This work is not peer-reviewed.
All our previous output on this subject can be seen at this weblink:
www.sciencemediacentre.org/tag/covid-19
Declared interests
Dr Nick Cammack: “The RECOVERY trial receives core funding from a number of funders, including Wellcome. Wellcome co-leads the Therapeutics Partnership of the ACT-Accelerator.”
Prof Stephen Evans: “No conflicts of interest. I am funded (one day per week) by LSHTM. They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator on any grants obtained from them. I am the statistician to the ‘meta-Data Safety and Monitoring Board’ for CEPI. I am paid for my attendance at those meetings and will be paid expenses for travel if that occurs.”
Dr Sheuli Porkess: “Dr Sheuli Porkess is Director of Actaros Consultancy Ltd. and clients include the Association of the British Pharmaceutical Industry.”
Dr Stephen Griffin: “No conflicts.”